A comparative study of low-dose bowel preparation agent, ORA-FANG tablet and Plenvu powder
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006149
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Background: Proper bowel preparation during colonoscopy is important because it can affect the diagnostic accuracy of colonoscopy. Various low-capacity intestinal cleansers are being developed to improve the quality of intestinal cleansers and make them more convenient for patients to use. We aimed to check the efficacy and safety of low-dose intestinal cleansers. Methodology: A study conducted in a single center in a positive, random and single-blind manner. Patients who agreed to participate in the study will be randomly assigned to either the Oralsulfate solution (OSS) or 1L polyethyleneglycol (PEG)+ascorbate for the study. Based on the Boston Intestinal Preparation Scale (BBPS), the degree of intestines, patient satisfaction, and side effects were evaluated. Results: 171 patients were eventually analyzed. There was no significant difference (95.4% OSS; 96.4% 1LPEG + ascorbate; p=0.736) in the degree of adequate preparation (BBPS total score =6 and each segment score =2). Satisfaction with drug use was significantly higher in the OSS group (p<0.001), and the frequency of side effects was low in the OSS group (26.4% OSS; 50.0% 1L PEG+ascorbate; p<0.001). Side effects in both groups were minor and recovered without special treatment. Conclusion Both OSS and 1LPEG+ascorbate, which are low-capacity bowel cleaners, are effective in intestinal cleansing and no serious side effects have been reported.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 184
1. Patients hospitalized for colonoscopy treatment such as polypectomy
2. Patients who are asymptomatic and visited the gastroenterology department for screening or surveillance colonoscopy for colon cancer screening purposes
1. Men or women under the age of 18
2. Patients with chronic bowel disease, including inflammatory bowel disease
3. Patients with massive bloody stool
4. Patients with renal dysfunction (CKD stage IV or higher)
5. Patients for the purpose of follow-up after colon cancer surgery and pret-reatment before colon surgery
6. People with mental retardation or cognitive impairment who are unable to make voluntary decisions
7. When other researchers judge that participation in research is inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Boston bowel preparation scale;Cecal intubaiton;Insertion time
- Secondary Outcome Measures
Name Time Method Satisfaction with taking;Compliance;Satisfaction with flavor;Willingness to switch to another bowel preparation drug;Willingness to reuse the same bowel preparation drug;Dosage;Adverse event